The process by which in­sti­tu­tion­al re­view boards over­see clin­i­cal tri­als needs re­forms that are "big and dif­fer­ent" so that the US can keep pace with Chi­na, FDA Com­mis­sion­er Mar­ty Makary said.

The FDA has to look "at the en­tire process" and short­en the time frame for clin­i­cal tri­al spon­sors from Phase 1 meet­ing re­quests to in­ves­ti­ga­tion­al new drug ap­pli­ca­tions, Makary told at­ten­dees Mon­day at the 2026 CMS Qual­i­ty Con­fer­ence in Bal­ti­more.

"Chi­na is ini­ti­at­ing four times the clin­i­cal Phase 1 tri­als as the Unit­ed States," Makary said, speak­ing along­side CMS Ad­min­is­tra­tor Mehmet Oz and NIH Di­rec­tor Jay Bhat­tacharya. The pre-IND phase runs about 380 days in the US, Makary said, while Chi­na is about 220 days and "they just an­nounced they're go­ing to go to 60."

Bio­Marin will stop dos­ing some pa­tients in two of its mid-stage stud­ies for Vox­zo­go af­ter a hip-re­lat­ed safe­ty con­cern was flagged in two in­de­pen­dent tri­als.

Sev­er­al cas­es of slipped cap­i­tal femoral epi­ph­ysis, or SCFE, were ob­served in the two in­ves­ti­ga­tor-spon­sored tri­als, Bio­Marin an­nounced Mon­day. SCFE can cause pain or a limp, and usu­al­ly re­quires surgery. As a re­sult, the com­pa­ny said it is dis­con­tin­u­ing en­roll­ment and dos­ing in its Phase 2 tri­als for Vox­zo­go in pa­tients with a hand­ful of ge­net­ic con­di­tions that can lead to short stature: Turn­er syn­drome, SHOX de­fi­cien­cy and Ag­gre­can de­fi­cien­cy.

Bio­Marin said no cas­es of SCFE have been re­port­ed in its own Phase 2 tri­als in those con­di­tions, or in its tri­als for bone growth dis­or­ders called hypochon­dropla­sia or achon­dropla­sia. The com­pa­ny al­so said no cas­es have been re­port­ed in post-mar­ket­ing sur­veil­lance.

Struc­ture Ther­a­peu­tics has its much-an­tic­i­pat­ed oral GLP-1 da­ta, and the re­sults look to give the next-gen­er­a­tion con­tender a chance against mar­ket in­cum­bents Eli Lil­ly and No­vo Nordisk.

The biotech said Mon­day that its once-dai­ly pill aleniglipron led to place­bo-ad­just­ed mean weight loss of 16.3%, or about 39 pounds, at the 180 mg dose at 44 weeks in Phase 2. On the 240 mg dose, the place­bo-ad­just­ed weight loss was 16%.

Leerink Part­ners an­a­lyst David Risinger de­scribed the da­ta as “best-in-class weight loss” in a note to clients. Struc­ture’s stock GPCR was up about 7% at mid­morn­ing, bring­ing the com­pa­ny’s mar­ket cap above $4 bil­lion.

The re­sults come from the small mol­e­cule biotech’s Phase 2 AC­CESS pro­gram, which in­cludes mul­ti­ple stud­ies in pa­tients with obe­si­ty or over­weight with at least one weight-re­lat­ed co­mor­bid­i­ty. Struc­ture re­port­ed ear­li­er da­ta on the drug in De­cem­ber.

Cir­Code Bio­med, a Chi­nese start­up work­ing on an ex­per­i­men­tal class of ge­net­ic med­i­cines known as cir­cu­lar RNA, has re­ceived the FDA's bless­ing to be­gin a clin­i­cal tri­al in the US, the com­pa­ny told End­points News in an ex­clu­sive in­ter­view.

The Shang­hai-based start­up ap­pears to be on­ly the sec­ond drug­mak­er with FDA clear­ance to test a cir­cu­lar RNA ther­a­py. The first was Ri­boX Ther­a­peu­tics, al­so based in Shang­hai, which be­gan its own US tri­al last spring, End­points pre­vi­ous­ly re­port­ed. Three well-fund­ed Boston star­tups fo­cused on cir­cu­lar RNA — two of which were re­cent­ly ac­quired by Bris­tol My­ers Squibb and Eli Lil­ly — have yet to start clin­i­cal tri­als.

“I think Chi­na re­al­ly can be the lead­ing play­er,” Cir­Code CEO Chenx­i­ang Tang told End­points. “We're try­ing to prove that cir­cu­lar RNA can be a good drug. No one has proved that yet."